FDA Inspection 752777 — Canon Medical Systems USA Inc

Canon Medical Systems USA Inc — FEI 1000649926

The FDA completed an inspection of Canon Medical Systems USA Inc on Nov 4, 2011 in Deerfield Beach, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Nov 4, 2011
Fiscal Year
2012
Product Type
Devices
Project Area
Compliance: Devices
Location
Deerfield Beach, FL (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures
54121 CFR 820.70(c)Environmental control Lack of or inadequate procedures